ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Reported: August 21, 2019 Initiated: February 20, 2019 #Z-2283-2019
Product Description
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Reason for Recall
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- N/A
- Distribution
- US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295. Recalled by Luminex Corporation. Units affected: N/A.
Why was this product recalled? ▼
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2019. Severity: Moderate. Recall number: Z-2283-2019.
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